metformin hydrochloride

Generic: metformin hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-142
Product ID 33342-142_3ce6010c-10dd-4e6f-9517-d71c0489a7c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205330
Listing Expiration 2026-12-31
Marketing Start 2017-11-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342142
Hyphenated Format 33342-142

Supplemental Identifiers

RxCUI
860975 860981 861004 861007 861010
UNII
786Z46389E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name metformin hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA205330 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-142-10)
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-142-11)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-142-44)
source: ndc

Packages (3)

33342-142-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-142-10) 33342-142-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-142-11) 33342-142-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-142-44)

Ingredients (1)

metformin hydrochloride (850 mg/1)

Linked Drug Pages (1)

Metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ce6010c-10dd-4e6f-9517-d71c0489a7c5", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975", "860981", "861004", "861007", "861010"], "spl_set_id": ["623b3bc6-1b07-4a04-bc7a-7fc695adf063"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-142-10)", "package_ndc": "33342-142-10", "marketing_start_date": "20171101"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-142-11)", "package_ndc": "33342-142-11", "marketing_start_date": "20171101"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-142-44)", "package_ndc": "33342-142-44", "marketing_start_date": "20171101"}], "brand_name": "Metformin hydrochloride", "product_id": "33342-142_3ce6010c-10dd-4e6f-9517-d71c0489a7c5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "33342-142", "generic_name": "Metformin hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA205330", "marketing_category": "ANDA", "marketing_start_date": "20171101", "listing_expiration_date": "20261231"}